Boston Scientific obtains FDA approval for Emblem MRI S-ICD System

10 August 2016 (Last Updated August 10th, 2016 18:30)

Medical device firm Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, and magnetic resonance (MR) conditional labelling for all previously implanted Emblem S-ICD Systems.

Medical device firm Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, and magnetic resonance (MR) conditional labelling for all previously implanted Emblem S-ICD Systems.

The Emblem S-ICD Systems serve as treatment options for patients vulnerable to sudden cardiac arrest (SCA), which leaves the heart and vasculature untouched, decreasing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators.

Boston Scientific rhythm management chief medical officer Kenneth Stein said: "Now with FDA approval, patients receiving the Emblem MRI S-ICD System, as well as patients who previously were implanted with an Emblem S-ICD System, have reassurance they can safely undergo MR scans while remaining protected from cardiac arrest."

"The Smart Pass technology will help ensure patients receive therapy from the device when necessary by improving the Insight Algorithm."

The Smart Pass technology will help ensure patients receive therapy from the device when necessary by improving the Insight Algorithm, which identifies and categorises a heart rhythm for effective arrhythmia treatment.

This feature can be incorporated into the previously implanted Emblem S-ICD Systems through a software update.

The AF monitor of the Emblem MRI S-ICD System is a new detection tool developed to notify physicians after identifying AF to facilitate a more informed treatment decision for their patients.

Boston Scientific has also obtained the FDA approval for its ImageReady MR-Conditional Pacing System featuring Accolade MRI and Essentio MRI pacemakers as well as Ingevity MRI pacing leads to treat bradycardia.